Funding affects breast cancer drug trial results

[Guest guest]

Industry-funded clinical trials of breast cancer medicines report more

favorable results than research conducted independently, a new study

reports. Some 84 percent of company-supported drug studies published in

10 major medical journals in 2003 reported positive results about the

breast cancer drugs they investigated, according to an analysis by Dr.

Peppercorn, a cancer physician and researcher at University of

North Carolina-Chapel Hill's School of Medicine.

Non-industry supported studies were far less likely to be upbeat,

publishing favorable results just 54 percent of the time. The analysis is

to be published online next Monday in CANCER, the journal of the American

Cancer Society. It is the latest to raise questions about the role

pharmaceutical companies play in funding and shaping research used to

decide whether drugs are safe and effective.

But the connection between positive drug studies and industry funding has

raised concerns in recent years as the industry's role has grown. A

Harvard School of Public Health paper published in 2005 estimated that

drug companies finance up to 70 percent of all clinical trials done in

the United States.

Drug companies invested $15.5 billion in clinical trials during 2006,

according to the Pharmaceutical Research and Manufacturers of America,

the industry's lobby and advocacy group. " The pharmaceutical industry is

not only a major player, it is the major player, " said Peppercorn. " We

need to pay attention to this because we need to know if important

questions are not being asked. "

Peppercorn said drug companies may be less inclined to publish when

studies are negative. Or it could be that pharmaceutical companies are

" flat out better " at identifying medicines most likely to perform well in

clinical trials.

A new national clinical trials registry, administered by the federal

government, will track results from all registered trials, published or

not. That data will eventually make it easier to know whether

industry-backed trials actually produce better results, or whether drug

companies are burying their bad results by not publishing.

Herceptin, the only U.S.-approved treatment for a certain type of

aggressive breast cancer, was developed primarily through research paid

for by its manufacturer, Genentech. GlaxoKline, which is seeking FDA

approval for Tykerb, an experimental drug that targets the same

aggressive form of breast cancer, also has invested heavily in trials.

[Guest guest]

The relative statistics for Herceptin indicate that it increases

disease free survival rate by 50%. However the absolute statistics

tell another story. The disease free survival rate is 5.7% A very

careful reading of the Oct.5,05 New England Journel of Medicine review

of the two Herceptin studies will give you both the absolute and

relative statistics. Those studies were funded my the maker of the drug.

Ruth

>

> Industry-funded clinical trials of breast cancer medicines report more

> favorable results than research conducted independently, a new study

> reports. Some 84 percent of company-supported drug studies published in

> 10 major medical journals in 2003 reported positive results about the

> breast cancer drugs they investigated, according to an analysis by Dr.

> Peppercorn, a cancer physician and researcher at University of

> North Carolina-Chapel Hill's School of Medicine.

> Non-industry supported studies were far less likely to be upbeat,

> publishing favorable results just 54 percent of the time. The

analysis is

> to be published online next Monday in CANCER, the journal of the

American

> Cancer Society. It is the latest to raise questions about the role

> pharmaceutical companies play in funding and shaping research used to

> decide whether drugs are safe and effective.

> But the connection between positive drug studies and industry

funding has

> raised concerns in recent years as the industry's role has grown. A

> Harvard School of Public Health paper published in 2005 estimated that

> drug companies finance up to 70 percent of all clinical trials done in

> the United States.

> Drug companies invested $15.5 billion in clinical trials during 2006,

> according to the Pharmaceutical Research and Manufacturers of America,

> the industry's lobby and advocacy group. " The pharmaceutical industry is

> not only a major player, it is the major player, " said Peppercorn. " We

> need to pay attention to this because we need to know if important

> questions are not being asked. "

> Peppercorn said drug companies may be less inclined to publish when

> studies are negative. Or it could be that pharmaceutical companies are

> " flat out better " at identifying medicines most likely to perform

well in

> clinical trials.

> A new national clinical trials registry, administered by the federal

> government, will track results from all registered trials, published or

> not. That data will eventually make it easier to know whether

> industry-backed trials actually produce better results, or whether drug

> companies are burying their bad results by not publishing.

> Herceptin, the only U.S.-approved treatment for a certain type of

> aggressive breast cancer, was developed primarily through research paid

> for by its manufacturer, Genentech. GlaxoKline, which is

seeking FDA

> approval for Tykerb, an experimental drug that targets the same

> aggressive form of breast cancer, also has invested heavily in trials.

>

>

[Guest guest]

>

> The relative statistics for Herceptin indicate that it increases

> disease free survival rate by 50%. However the absolute statistics

> tell another story. The disease free survival rate is 5.7% A very

> careful reading of the Oct.5,05 New England Journel of Medicine review

> of the two Herceptin studies will give you both the absolute and

> relative statistics. Those studies were funded my the maker of the

drug.

> Ruth

While I am quite sure that drug companies, like most big corporations,

tend to enhance their statistics in their favor, I am quite sure the

opposite can be true, too.

I haven't been able to get my hands on the article you mention, but you

need to report several more things along with your numbers, otherwise

you can be just as misleading in the opposite direction, even if you

aren't intending to be:

Who is being treated? Early or late stage? Recurrent?

Which type of breast cancer? I gather it is HER2+, but do they specify

if there are differences if there are ER+/-, PR+/-?

When is the disease-free survival measured to? One year? Two? Five?

And I strongly suspect, based on how low the 'absolute' number you

quote is, that you are not giving the absolute disease-free survival

rate but rather the absolute *improvement* in disease-free survival

rate - up to a given time.

I'm sure not gonna say the drug companies and researchers are gods, but

they ain't the devil, either.

Breast cancer is not a single disease, which is why we're going on

about our ER/PR/HER2 status. There's inflammatory BC as well. Often the

research is trying to attack one of these specific types, and often a

specific stage of the disease. The drug study results need to be in

context of the specific type, because typically they are not claiming

their results are true for all BCs in general, just for the ones

they're studying.

Epidemiologic studies that are trying to find out what causes BCs or

other cancers generally are vaguer and more sweeping in their

generalizations. But it is a different level of science, and generally

not on as firm ground as the drug studies.

That said, I wouldn't be surprised if the drug companies sweep their

negative results under the rug rather than publishing them. No doubt

due to their lawyers, and also to the fear of what announced failures

do to their stock prices. But it is often true in research, that

scientists, especially the first ones to claim something, publish their

positive rather than their negative results. It's only after the first

positive study is published that people then feel comfortable in

publishing 'I don't get that result!' It's also sad but true that

often 'good' results that are published are just due to chance

variation, as well, and not necessarily due to any massaging of the

data. That's why it often takes so long before results from experiments

or trials can be *really* accepted as reasonable.

Ann